the Investigation Into Beneficial Effects of High-dose Interferon Beta 1-a, Compared to Low-dose Interferon Beta 1-a in Moderate to Severe Covid-19
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 主要终点
- Time to clinical improvement
研究概览
简要总结
The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
详细描述
According to previous studies, IFN-β has strong antiviral activity and also has an acceptable safety profile. Based on possible therapeutic effects, we decided to lead an Investigation into Beneficial Effects of high-dose Interferon Beta 1a, Compared to low-dose Interferon Beta 1a (the base therapeutic regimen) in Moderate to Severe COVID-19.
Previous studies demonstrate that IFN-β 1a could be used against some coronaviruses including avium infectious, bronchitis virus, murine hepatitis virus, and SARS- CoV because they are susceptible in vitro or in vivo. In a current study, the efficacy of IFN-β 1a in COVID-19 patients were evaluated, and they found than IFN-β 1a reduced the disease symptoms.
The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed)
- •at least one of the following: radiation contactless body temperature ≥37.5, cough, shortness of breath, nasal congestion/ discharge, myalgia/arthralgia, diarrhea/vomiting, headache or fatigue on admission.
- •Time of onset of the symptoms should be acute (Days ≤ 14)
- •NEWS2 ≥ 1 on admission (National Early Warning Score 2)
排除标准
- •Refusal to participate expressed by patient or legally authorized representative if they are present
- •Patients using drugs with potential interaction with Lopinavir/Ritonavir or Interferon-β 1a
- •Pregnant or lactating women.
- •History of alcohol or drug addiction in the past 5 years.
- •Blood ALT/AST levels > 5 times the upper limit of normal on laboratory results.
- •The patients who were intubated less than one hours after admission to the hospital
研究组 & 干预措施
Arm1
Lopinavir /Ritonavir +high dose Interferon-β 1a
干预措施: High dose Interferon-beta 1a (Drug)
Arm1
Lopinavir /Ritonavir +high dose Interferon-β 1a
干预措施: Lopinavir/Ritonavir (Drug)
Arm2
Lopinavir /Ritonavir + Low dose Interferon-β 1a
干预措施: Lopinavir/Ritonavir (Drug)
Arm2
Lopinavir /Ritonavir + Low dose Interferon-β 1a
干预措施: Low dose Interferon-beta 1a (Drug)
结局指标
主要结局
Time to clinical improvement
时间窗: From date of randomization until 14 days later
Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R\&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.
次要结局
- Mortality(From date of randomization until 14 days later)
- SpO2 Improvement(Days 1, 2, 3, 4, 5, 6, 7 and 14)
- Incidence of new mechanical ventilation use(From date of randomization until 14 days later)
- Duration of hospitalization(From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days)
- Cumulative incidence of serious adverse events(Days 1, 2, 3, 4, 5, 6, 7 and 14)
研究者
Ilad Alavi Darazam
Dr. Ilad Alavi Darazam, MD
Shahid Beheshti University of Medical Sciences